Trial of Oral Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
- Conditions
- Breast Neoplasm FemaleArthralgia
- Interventions
- Other: PlaceboDrug: Hyaluronic Acid (HA)
- Registration Number
- NCT03384095
- Lead Sponsor
- Erin Newton
- Brief Summary
This is a single center, double-blinded, placebo-controlled, randomized Phase II trial to determine whether oral hyaluronic acid will prevent aromatase inhibitor (AI)-associated arthralgias. Subjects must have ER/PR-positive breast cancer tumor with history of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) which resolved after cessation of their AI (anastrazole or letrozole) within 90 days of enrollment. Subjects will be stratified by initial AI, thus within each initial AI, subjects will be randomized to receive either the experimental treatment (hyaluronic acid) or placebo. Subjects will begin the assigned treatment for 2 weeks prior to transitioning to the second AI. Evaluations will be taken at baseline, 6 weeks (1 month on study drug and AI), 14 weeks (3 months on study drug and AI), and at 26 weeks (6 months on study drug and AI). Treatment with hyaluronic acid and placebo will last for 26 weeks total.
- Detailed Description
Primary Objective To determine whether oral HA will prevent AI-induced arthralgias and preserve physical function.
Secondary Objectives
1. To explore whether oral HA will have an acceptable safety and tolerability profile.
2. To determine whether oral HA will prevent other AI associated symptoms as assessed by patient reported outcomes (PRO's).
3. To assess how many of the subjects are 90% compliant with taking the HA as directed.
Exploratory Objective To determine if mi486, (a microRNA enriched in skeletal muscle) and other biomarkers associated with AIMSS (TNF, IL-6, IL-17) vary with the administration of HA.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects in this arm will be given a placebo comparator capsule that is identical to the hyaluronic capsule containing microcrystalline cellulose as the sole ingredient. Subjects in this arm will be asked to take 1 capsule twice daily for 26 weeks. Hyaluronic Acid Hyaluronic Acid (HA) Subjects in this arm will be given 100 mg of hyaluronic acid in capsule form. Subject in this arm will be asked to 1 capsule take twice daily for 26 weeks.
- Primary Outcome Measures
Name Time Method Difference in mean change in joint pain between HA and placebo groups 14 weeks As measured by the Brief Pain Inventory - Short Form (BPI-SF) questions #3-#6, #9A-G. This 14-item questionnaire was developed for use in patients with cancer that uses a scale from 0 to 10 to assess worst pain, pain severity, and pain interference over the past week. The first 8 items have to do with the severity of the pain, and the remaining 7 items ask about how the pain has affected function.
- Secondary Outcome Measures
Name Time Method Difference in mean quality of sleep between HA and placebo groups 6, 14, and 26 weeks As measured by Pittsburgh Sleep Quality Index (PSQI) scores. This an 18-item instrument produces a global sleep-quality score and the following component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction.
Difference in mean change in WOMAC subscale 3 scores between HA and placebo groups 6, 14, and 26 weeks As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 3 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Proportion of patients that remain on second aromatase inhibitor between HA and placebo groups 26 weeks As measured by patient self-report of mediation compliance (medication diary) and chart review
Mean frequency of as needed analgesia between HA and placebo groups 6, 14, and 26 weeks As measured by patient self-report of mediation compliance (medication diary)
Difference in mean change in WOMAC subscale 2 scores between HA and placebo groups 6, 14, and 26 weeks As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 2 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Rate of 90% compliance between HA and placebo groups 26 weeks As measured by patient self-report of mediation compliance (medication diary)
Difference in global change between HA and placebo groups 6, 14, and 26 weeks As measured by Patient's Global Impression of Change scale (PGIC) scores
Difference in mean change in WOMAC subscale 1 scores between HA and placebo groups 6, 14, and 26 weeks As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 1 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Incidence of treatment-emergent adverse events (i.e. safety and tolerability of HA) 30 weeks Summary of adverse events as measured by CTCAE v4.0
Difference in mean joint symptoms between HA and placebo groups 6, 14, and 26 weeks As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Difference in mean joint function between HA and placebo groups 6, 14, and 26 weeks As measured by Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH) scores. This 11-item instrument assesses physical function and symptoms in patients with musculoskeletal disorders of the upper limbs. It is a questionnaire scored from 1 to 5, with the higher score indicating worse symptoms, and there is a validated method to calculate a single Disability/Symptom Score.
Time to discontinuation of second aromatase inhibitor due to AIMSS between HA and placebo groups 26 weeks As measured by patient self-report of mediation compliance (medication diary) and chart review
Trial Locations
- Locations (4)
Indiana University Health Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Indiana University Health North Hospital
🇺🇸Carmel, Indiana, United States
Indiana University Health Hospital
🇺🇸Indianapolis, Indiana, United States
Spring Mill Medical Center
🇺🇸Indianapolis, Indiana, United States